Impact of Cuddle and Calm Booklets on Parent-Child Emotional Connection a Nurture-based Children's Book

NCT05739760 | Withdrawn

• 1 other identifier: AAAT2041
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Children's social and emotional development is affected by their relationship with their parents. The goal of the study is to test an intervention that guides parents and children to strengthen their relational health and navigate difficult situations. This study will begin in the well-child visit in the pediatric department at MetroHealth Medical Center. Pediatricians will invite families to enroll in the study, then study personnel will administer two illustrated poem books called "Cuddle and Calm," a poetry book with tips on how to strengthen the parent-child relationship, or "Health and Safety," a poetry book with tips on how to avoid injuries. This intervention is based on the construct of emotional connection as studied by Martha G Welch MD, who developed the Welch Emotional Connection Screen (WECS) along with Amie Hane PhD. The WECS-Parent Report (WECS-PR) is a likert scale parent-report screen with items regarding the domains featured in the WECS.

Conditions

Emotional Problem

Outcome Measures

Primary Outcomes (1)

• Change in Tantrum Questionnaire Score

  Determine whether mother-child dyads who received "Cuddle and Calm," had better scores on the tantrum questionnaire compared to the dyads who received the control book poem books, "Health and Safety."

  Change from baseline to 4 weeks post book reading

Secondary Outcomes (1)

• Welch Emotional Connection Screen - Parent Report

  change from baseline to 4 weeks post book reading

Other Outcomes (1)

• Book Acceptability Questionnaire Score

  4 weeks after receiving designated books

Study Arms (2)

Families assigned the "Cuddle and Calm" booklet

EXPERIMENTAL

A poem about emotional expression in times of upset

Behavioral: Poem book about relational health

Families assigned the "Health and Safety" booklet

EXPERIMENTAL

A poem about health and safety with tips on topics such as first aid and injury prevention

Behavioral: Poem book about physical health and safety

Interventions

Poem book about relational health BEHAVIORAL

Poem book will consist of illustrations, poetry, and tips for parents on how to resolve their child's upset, their own upset, and to develop a stronger relationship. The study physician may read the book to the families at the visit. Then, families are instructed to read the book at least once, for as many times as the parent opts to.

Also known as: "Cuddle and Calm" booklet

Families assigned the "Cuddle and Calm" booklet

Poem book about physical health and safety BEHAVIORAL

Poem book will consist of illustrations, poetry, and tips for parents on how to keep their child physically healthy and safe, and to avoid accidental injuries. The study physician may read the book to the families at the visit. Then families are instructed to read the book at least once, for as many times as the parent opts to.

Also known as: "Health and Safety" booklet

Families assigned the "Health and Safety" booklet

Eligibility Criteria

• Age: 18 Months - 80 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children between 18 months and 6 years old and their mothers or grandmothers, if primary caregiver, scheduled for a well visit.

You may not qualify if:

• Refusal to consent
• Inability to access internet; not having an email address.

Sponsors & Collaborators

• Columbia University: lead

MeSH Terms

Interventions

Safety; Health

Intervention Hierarchy (Ancestors)

Accident Prevention; Accidents; Public Health; Environment and Public Health; Population Characteristics

Study Officials

• Martha G Welch, MD

  Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology) at the Columbia University Medical Center

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: February 22, 2023
• Study Start: May 1, 2021
• Primary Completion: January 21, 2022
• Study Completion: January 21, 2022
• Last Updated: February 22, 2023

Record last verified: 2023-02